Who is this study for?
The study is looking at parents of children who have completed frontline treatment for neuroblastoma, had a period of time off treatment and then their neuroblastoma returns if they had no evidence of disease (relapse) or starts to grow again if their disease was stable (progression). Families who make a treatment decision at this point, or a treatment decision at any point in the future, are eligible to participate in the study at the time such a decision is made.
What is involved in participating?
Parents of a child with relapsed neuroblastoma who have recently made a decision about treatment can take part in an interview. The purpose of these interviews is to understand how parents made their most recent treatment decision and how their decision-making may have changed over time (if they have made previous decisions about treatment). This will build a picture of how parents make a series of repeated treatment decisions to inform the decision aid (phase 2).
Parents will be interviewed at different decision points following relapse or disease progression (as defined above) where a treatment decision has been made. A need for a treatment decision can be related to anything which requires a change to the treatment a child is currently receiving for example treatment toxicity, partial response or progressive disease.
What is the criteria to be able to participate?
- Parents of a child who is receiving treatment for relapsed neuroblastoma
- Child is under 12 years of age at relapse. This is because there is decision-making research involving those who are 12 years and over. As this is a decision aid for parents, children are not being interviewed.
- Parents can be re-interviewed if they make more than one treatment decision during the time phase 1 is open
How will parents be asked to participate in the study?
Parents can participate in the study via 2 routes:
1) Participant Identification Centres (PIC): Parents will be approached about REDMAPP by a healthcare professional in their Primary Treatment Centre if the centre has agreed to be a PIC. PICs are centres which identify potential participants for research studies and then the research is undertaken by an independent research team (see Research Team page). Parents will be given a parent information pack which contains information about the study and asked whether they would be happy for Helen Pearson to contact them to discuss the study. If parents agree to be contacted, they will be asked to sign a consent form to allow their contact details to be shared with Helen. The healthcare professional will then forward these details (name, phone number and email address if applicable) to Helen. Parents will be contacted by Helen a minimum of 24 hours after she has received the parent contact details. This gives time for parents to review the parent information pack. When Helen contacts the parent it is to discuss the study further and answer any questions they may have. Parents can then decide to participate or decline being involved in the REDMAPP study. Speaking with Helen does not mean parents have to participate.
Participant Identification Centres:
Below is a list of Primary Treatment Centres which are confirmed as participating in phase 1:
- Manchester University NHS Foundation Trust
- Royal Aberdeen Children’s Hospital (NHS Grampian)
- University Hospital Southampton NHS Foundation Trust
- University Hospital of Wales (Cardiff)
This list will be updated as more Primary Treatment Centres open.
Parent Self-Referral to REDMAPP:
2) Parents who may like to participate in the study and their Primary Treatment Centre is not listed as a PIC are able to self-refer to the study. Parents can self-refer either through completing the contact form below or by direct message on @redmapp_study twitter or Instagram page or Research Study Facebook page.
This self-referral means Helen can send the parent information pack to the email address provided and arrange a follow-up phone call to discuss the study a minimum of 24 hours later. This gives time for parents to review the parent information pack. When Helen contacts the parent it is to discuss the study further and answer any questions they may have. Parents can then decide to participate or decline being involved in the REDMAPP study. Speaking with Helen does not mean parents have to participate.
What happens if a parent agrees to participate?
If a parent agrees to participate in the study, an interview will be arranged at a time and location which is convenient for the parent. This can be face-to-face, by telephone or video call (ie: Zoom or Microsoft Teams). The interview date/time/location will be organised at the time a parent agrees to participate in the study (this would be when the parent and Helen speak to discuss the study). Consent will be taken at the time of the interview. A copy of the consent form is in the parent information pack so parents can read this in advance to understand what they are consenting to.
The interview has questions around what is important when making treatment decisions, who is involved in making these decisions and whether with the more decisions parents make their views change in how they make these decisions. The questions are a guide to start the interview and the conversation will be directed by what parents want to discuss around their decision-making experiences.
We encourage both mothers and fathers, who are involved in their child’s care, to participate as we know from previous research literature that the experiences of fathers is under represented.
How long will phase 1 be open for?
Phase 1 opened in February 2020 and was put on hold in March 2020 due to Coronavirus. The study has now reopened and it is anticipated this phase will be open until January 2022. This is subject to the number of parents that have participated up to that time point. For the study to be of value to parents, we have to ensure we capture a broad view of parent experiences of making repeated treatment decisions so that the decision aid is valuable and useful.